1. Field of the Invention
The invention relates to a cutaneous harness for wound closing without sutures, and therefore without any perforation of the skin adjacent to the wound.
2. Description of Prior Art
The body's first lines of defense against infection are the barriers offered by surfaces exposed to the external environment. Very few microorganisms can penetrate the intact skin. Once invaders gain entry into the skin, it disturbs inflammation, the response to injury. The local manifestations of the inflammatory response are a complex sequence of highly interrelated events, the overall functions of which are to bring neutrophils and phagocytes into the damaged area so that they can destroy (or inactivate) the foreign invaders and set the stage for tissue repair. The sequence of events which constitute the inflammatory response varies, depending upon the injurious agent (bacteria, cold, heat, trauma, etc.), the site of injury, and the state of the body. It should be emphasized that inflammation, in its most basic form, is the nonspecific innate response to foreign material.
Wound healing is a complex cascade of cellular and biochemical events which lead to wound closure and repair of tissues. Three successive phases are classically distinguished in this process:
1) the inflammatory phase, corresponding to increased vascular permeability and migration of neutrophils, leukocytes and macrophages;
2) the proliferative phase, characterized by fibroblast proliferation and collagen synthesis, resulting in granulation tissue formation; and
3) the remodeling phase, where collagen and granulation tissue rearrangements results in scar resorption.
Sutures are well known to involve tying adjacent lips of wound together at intervals along the length of the wound. This provides an unsatisfactory closure of the wound because the epithelium cells of the skin of the adjacent lips are, at intervals, either in too close proximity or too distant from one another for adequate healing of the wound. Furthermore, sutures, although they are efficient in closing a wound, perforate the skin adjacent to the wound site and cause micro-inflammatory responses adjacent to the wound site. There are great advantages in providing a means to close a wound without causing this undesired micro-inflammation adjacent to the wound site.
Various types of appliances have previously been proposed for providing sutureless closure of surgical incisions. For example, U.S. Pat. Nos. 345,541, 1,428,495, 1,774,489, and 2,387,131 and Italian Patent No. 692,496 disclose adhesive members which are joined together by suitable lacing which can be tightened. All these devices are flexible in two-dimension only and cannot follow the edges of transversely non-linear or curved wounds. Thus, these devices cannot ensure the adequate closure of non-linear wounds.
In U.S. Pat. No. 2,752,921 there is disclosed essentially an adhesive tape formed in two halves which may be brought together by a zip fastener among others. The wound edges must follow the line of the fastener very accurately if the skin edges are to be brought together correctly by closure of the fastener. Moreover a zip fastener does not produce a sufficient closing action to ensure that the skin edges are brought together and held immobile relative to one another. Again, this device is not flexible in the plan of the wound and cannot follow non-linear lips of a curved wound.
U.S. Pat. No. 3,983,878 discloses an appliance which enables the closure of a surgery wound to be made very rapidly and which may be designed to ensure minimum movement of the skin edges relative to one another. This appliance consists in a tape member which has an adhesive surface for fastening to the skin of a surgery patient and a series of parallel ribs defining a course along which an incision through the tape and the skin beneath can be made. This appliance also includes a spring closure member applicable to ribs of the tape member and to be clasped in a closed position for wound closure. This appliance is designed to be used in surgical procedures to produce linear incisions. This appliance is not flexible in the plan of the incision and cannot provide for adequate closure of non-linear incisions.
German Patent No. 111,345 describes a strip having one longitudinal part being adhesive and another longitudinal part attached thereto being provided with lacing means. The adhesive portion of the strip is formed of a plurality of teeth which seems to be flexible in three-dimension but the lacing portion is formed of one-piece only and cannot be flexed to follow a curved wound.
None of these methods ensures that the non-linear lips of a curved skin wound will be held together properly and at an appropriate distance for healing of the wound to occur.
It would be highly desirable to provide a sutureless closure means which would be flexible in three-dimension and which would allow for an isotensiometric closure of curved or straight wounds. Such an isotensiometric closure of wounds would permit for the rapid healing of wounds, and hence, recovery of patients at a faster rate and with less infection wound problems and scaring side effects.
Moreover, none of the appliances of the prior art ensures the visibility of the wound and its access once held in a closed position. Also, none of the appliances of the prior art allows for the rapid access to the wound in case of an emergency.